How to Prepare for ISO 13485 Certification Process - Step by Step [for auditee organizations]

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Establish the Implementation project

Project Plan

Project Resources

Conduct ISO 13485 Awareness Training

Identify Implementation Team

Conduct ISO 13485 Implementation Training

Define ISO 13485 Context

Define ISO 13485 Scope

Define ISO 13485 Policy

Define ISO 13485 RA & RT

Implement ISO 13485 Operational Controls

Conduct ISO 13485 Pre-assessment Audit

Define ISO 13485 Objectives

Conduct ISO 13485 Internal Auditor Training

Close the Gaps and Proceed for Certification Audit

Define ISO 13485 Documented Information

Conduct Internal Audits, Closures, Management reviews

Monitoring, Measurement and Performance Evaluation

Communication with Interested Parties

Obtain Top Management’s Committment


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